Cannabis Observations on Brain Waves, Retrieval, and Attention: Experiment 4

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-40
SponsorL. Cinnamon Bidwell

About this trial

This study investigates the impact of ∆9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on recognition memory in healthy, regular cannabis users. Participants complete the same recognition memory task after self-administering one of two different strains of cannabis flower one day and while not intoxicated another day. Event-related potentials (ERPs) are measured via electroencephalogram (EEG) during the recognition memory task. Blood is collected to quantify THC and CBD exposure. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must be between the ages of 21 and 40 and provide informed consent;

Must be right-handed (Laterality Quotient > 60 on Edinburgh Handedness Inventory - Short Form136);

Must use cannabis at least 4 days during the month;

Must be a cannabis user for at least a year;

Disqualifiers

None

Trial population

Community sample of healthy, regular cannabis users in the Boulder/Denver areas.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cannabis (smoked flower)

    Drug

    Self directed use (ad libitum)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Difference in ERP amplitude (FN400)

The FN400 event-related potential (ERP) old/new effect will be measured using electroencephalography (EEG) during a recognition memory test. The FN400 reflects familiarity-based memory retrieval and is defined as the mean ERP amplitude difference between correctly recognized previously presented items ("hits") and correctly rejected novel items ("correct rejections") at mid-frontal electrode sites during the 300-500ms post-stimulus interval.

Time frame
Intoxicated session and not-intoxicated session (about 1 week)
2

Difference in ERP amplitude (parietal)

The parietal ERP old/new effect will be measured using EEG during a recognition memory test. The parietal old/new effect reflects recollection-based memory retrieval and is defined as the mean ERP amplitude difference between hits and correct rejections at parietal electrode sites during the 500-800ms post-stimulus interval.

Time frame
Intoxicated session and not-intoxicated session (about 1 week)
3

Difference in retrieval memory accuracy

Behavioral accuracy during recognition memory test will be assessed by the number of hits and correct rejections made during memory recall. Retrieval memory accuracy will be compared between intoxicated and not-intoxicated sessions.

Time frame
Intoxicated session and not-intoxicated session (about 1 week)
4

Difference in retrieval memory performance

Memory performance will be assessed via reaction time, measured by a photocell during recognition memory testing and concurrent EEG. During the recall phase, a light indicator will appear in the bottom-right corner of the stimulus screen when a prompted image is presented, activating the photocell. This indicator disappears once the participant responds. The interval between stimulus onset and the participant's "new" or "old" response is used as the reaction time measure for both intoxicated and non-intoxicated sessions. Retrieval memory performance will be compared between intoxicated and not-intoxicated sessions.

Time frame
Intoxicated session and not-intoxicated session (about 1 week)

Secondary outcomes

1

Change in Positive and Negative Affect Schedule (PANAS)

The PANAS is a Self-report measurement of positive and negative affect that will be administered at all times of the Mobile sessions: the pre-use and post-use timepoints of the intoxicated session, well as the not-intoxicated session. The PANAS will be used twice at the intoxicated session to measure changes in mood before and after cannabis use. The survey presents a 20-item scale from 1 (very slightly or not at all) to 5 (extremely), with a higher score on the positive affect scale indicating higher positive affect and a higher score on the negative affect scale indicating higher negative affect.

Time frame
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
2

Change in Drug Effects Questionnaire (DEQ)

The DEQ is a 5-item visual analogue scale that measures acute drug effects, with prevalent use across numerous drug studies. Specifically, the questionnaire measures strength of the effects of cannabis as well as the desirability of the effects. Participants answer questions on a range from 0 - 100, with higher values for each item indicating greater drug effect or desire. The specific items related to drug "liking" and "wanting more" have been associated with harmful drug use. Participants will be administered the DEQ at all time points of the Mobile sessions to assess differences following intoxication.

Time frame
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
3

Change in Addiction Research Center Inventory (ARCI-M)

The ARCI-M is a self-report measure of subjective effects of marijuana in addition to drug-induced euphoria, stimulant-like effects, intellectual efficiency and energy, sedation, dysphoria, and other somatic effects. This is a 12 item true-false task, in which higher (true) scores indicate greater intoxication. Participants will be administered the ARCI-M at all time points of the Mobile sessions to assess differences following intoxication.

Time frame
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
4

Change in Marijuana Craving Questionnaire (MCQ)

The Marijuana Craving Questionnaire is a self-report measure of marijuana craving that will be administered at all time points during the Mobile sessions. Participants complete 8 questions ranging from 0 - 10, with a higher score indicating greater cannabis craving and somatic symptoms. The primary focus of this questionnaire will be the effect of intoxication on reporting.

Time frame
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session

Other outcomes

1

Exploratory: Correlations between genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function with ERPs and recognition memory performance

DNA will be extracted from 3.0 ml of blood from the baseline session. After extraction, DNA will be quantified and stored at -80° for analysis. DNA will be collected to look at differences in epigenetic and single nucleotide polymorphisms (SNPs) in participants. Due to the rapidly changing landscape of genetic science, the DNA samples collected in this study are primarily for bio-banking purposes. The analysis of these genetic samples is expected to be performed at a future date to contribute to the current study and/or future studies. Participants will be allowed to opt out of storage of genetic samples for future research.

Time frame
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
2

Exploratory: Moderation of primary effects by baseline sleep quality using the Patient-Reported Outcomes Measurement Information Systems (PROMIS)

Baseline measurement of sleep disturbance, assessing participant's quality and patterns of sleep over the last seven days. Participants complete 4 items, for a total scale score from 4 - 20, with higher scores indicating more sleep disturbance.

Time frame
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
3

Exploratory: Moderation of primary effects by baseline affective symptoms using the Depression Anxiety Stress Scale (DASS)

Baseline assessment of affective symptoms. Participants complete the Depression, Anxiety, and Stress Scale-21 (DASS-21), a 21-item measure consisting of three 7-item subscales assessing depression, anxiety, and stress/tension. Higher scores indicate greater symptom severity within each domain. Acute drug-effect measures will be collected at each study session, including before and after participants self-administer their assigned cannabis strain during mobile laboratory sessions.

Time frame
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
4

Exploratory: Moderation of primary effects by baseline substance use history using the Timeline Followback (TLFB)

The TLFB is used to assess daily substance use for 30 days prior to the Baseline Appointment and 3-7 days prior to the later sessions. Our modified TLFB procedure will estimate both frequency of marijuana use and amount used per day, using visual stimuli as well as the method of administration.

Time frame
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

L. Cinnamon Bidwell

Lead sponsor

University of Colorado, Boulder

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator